Pediatric Elective Intubation With and Without Muscle Relaxation Utilizing the Shikani Optical Stylet

Rady Children's Hospital

Status: Terminated

Conditions: Intubation,Endotracheal

Treatments: Drug: Cisatracurium; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT00912990

11672

06104C (Other Identifier)

Details and patient eligibility

About

The investigators' primary specific aims are to demonstrate that:

1. Pediatric patients with normal airways, undergoing elective surgical procedures, can be successfully intubated when deeply sedated, without the use of muscle relaxants using the Shikani Optical Stylet.

2. Shikani intubation of pediatric patients is equally effective in children that are deeply sedated or paralyzed as evidenced by a non-significant difference in:

   • Time to intubation (defined as no more than a 30 second time difference between the two groups);
   • Incidence of adverse events.

Enrollment: 34 patients

Sex: All

Ages: 6 months to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 6 months of age to 17 years of age (not yet 18)
• Male or female
• English or Spanish speaking
• Normal airway (Mallampati Classification )
• American Society of Anesthesiology Physical Status Classification I or II
• Elective surgical procedure expected to last at least 45 minutes in length
• Written informed consent/assent for participation given by the parent legal guardian and subject (if applicable)

Exclusion criteria

• < 6 months of age, > 17 years of age

• Difficult airway (Mallampati Classification)

• History of previous difficult intubation, suspected abnormal airway: *micrognathia

  • facial trauma
  • airway tumor
  • epiglottitis
  • retropharyngeal abscess
  • foreign body, etc.
  • Scheduled for non-elective, emergent OR procedure
  • Parent, legal guardian, or subject is unavailable or unwilling to consent for study participation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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34 participants in 2 patient groups, including a placebo group

Normal saline

Placebo Comparator group

Description:

Normal saline volume calculated to be equal to the volume of cisatracurium 0.2mg/kg

Treatment:

Drug: Normal saline

Cisatracurium

Active Comparator group

Description:

Subjects in this arm will be given Cisatracurium 0.2mg/kg IV dose one time prior to intubation.

Treatment:

Drug: Cisatracurium